21 U.S.C. § 393a | Office of Pediatric Therapeutics

(a)

Establishment

The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Drug Administration.

(b)

Duties

The Office of Pediatric Therapeutics shall be responsible for coordination and facilitation of all activities of the Food and Drug Administration that may have any effect on a pediatric population or the practice of pediatrics or may in any other way involve pediatric issues, including increasing pediatric access to medical devices.

(c)

Staff

The staff of the Office of Pediatric Therapeutics shall coordinate with employees of the Department of Health and Human Services who exercise responsibilities relating to pediatric therapeutics and shall include—

(1)

one or more additional individuals with expertise concerning ethical issues presented by the conduct of clinical research in the pediatric population;

(2)

section 355a of this title section 355c of this title subject to subsection (d), one or more additional individuals with necessary expertise in a pediatric subpopulation that is, as determined through consideration of the reports and recommendations issued by the Institute of Medicine and the Comptroller General of the United States, less likely to be studied as a part of a written request issued under or an assessment under ;

(3)

one or more additional individuals with expertise in pediatric epidemiology; and

(4)

one or more additional individuals with expertise in pediatrics as may be necessary to perform the activities described in subsection (b).

(d)

Neonatology expertise

At least one of the individuals described in subsection (c)(2) shall have expertise in neonatology.

Pub. L. 107–109, § 6Jan. 4, 2002115 Stat. 1414 Pub. L. 110–85, title III, § 306(a)Sept. 27, 2007121 Stat. 864 Pub. L. 112–144, title V, § 511July 9, 2012126 Stat. 1050 Pub. L. 115–52, title V, § 505(d)(1)Aug. 18, 2017131 Stat. 1047(, , ; , , ; , , ; , , .)

Editorial Notes

Codification

Section was enacted as part of the Best Pharmaceuticals for Children Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Amendments

Pub. L. 115–52July 9, 20122017—Subsec. (d). substituted “At least” for “For the 5-year period beginning on , at least”.

Pub. L. 112–144, § 511(1)2012—Subsec. (c)(2) to (4). , added pars. (2) and (3) and redesignated former par. (2) as (4).

Pub. L. 112–144, § 511(2)Subsec. (d). , added subsec. (d).

Pub. L. 110–852007—Subsec. (b). inserted “, including increasing pediatric access to medical devices” before period at end.